A bioequivalence study between Pregabalin SR 300mg tablet (Test, Torrent Pharmaceuticals Ltd., India) and Pregabalin SR 300mg tablet (Reference, LYRICATM of Pfizer Gmbh, Germany) as reference was carried out in 24 healthy human volunteers under fed condition. The study design used was an open label, randomized, two period, two treatments, crossover, and bioavailability study. Blood samples were taken before, and up to 36 hrs after drug administration. Plasma samples were analyzed to quantify the concentration of pregabalin using a validated LC-MS/MS bioanalytical method. The pharmacokinetic parameters, Cmax and Tmax, were obtained directly from plasma concentration data, Kel was estimated by linear least-square regression analysis using the last three (or more) non-zero plasma concentrations, and the Area under Curve (AUC) was calculated by the linear trapezoidal rule. When Cmax, AUC0-t and AUC0-inf were analysed using analysis of variance, no statistically significant difference was observed between the two different Pregabalin SR 300mg tablet under fed conditions. The 90% confidence interval for pregabalin log transformed parameters (AUC0-t) and (AUC0-inf) were 97.87 to 104.00 and 96.54 to 101.79 respectively. All of these values were within the bioequivalence acceptance range of 80-125%. We found that both formulations were bioequivalent and therefore interchangeable in clinical practice.
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